What are the responsibilities and job description for the Senior Manufacturing Quality Engineer position at X4 Life Sciences?
Senior Manufacturing Quality Engineer | Medical Devices
About the Opportunity
At X4 Life Sciences, we’re partnered with a well-established medical device company entering an exciting period of expansion. They’re looking to bring on a Senior Manufacturing Quality Engineer to support quality activities across manufacturing and installation.
What You’ll Be Doing
- Collaborating with cross-functional teams to investigate and resolve quality-related issues
- Leading risk assessments and implementing effective risk control strategies
- Ensuring compliance with quality systems and applicable regulatory requirements
- Supporting and driving CAPA activities within your area of responsibility
- Reviewing and approving engineering change orders and quality documentation
- Applying statistical techniques to analyse data and identify improvement opportunities
- Contributing to process validation work (including IQ/OQ/PQ and Gauge R&R)
- Supporting both internal and external audit processes
- Overseeing non-conformance investigations for products and processes
- Assisting in the development, validation, and implementation of test methods
- Maintaining product risk management files and documentation
- Supporting wider QA and operational initiatives as required by leadership
What We’re Looking For
- Minimum of 4 years’ experience in Manufacturing or Operational Quality within the medical device sector
- Strong background in non-conformance management and continuous improvement initiatives
- Solid understanding of regulatory frameworks such as 21 CFR820, ISO13485, and ISO14971
- Bachelor’s degree in Engineering or a related technical discipline (Mechanical, Electrical, etc.)
Nice To Haves
- Experience applying statistical tools and methodologies
- Exposure to products requiring on-site installation
- Lean Six Sigma (DMAIC/DFSS Green or Black Belt)
- Experience working with complex devices, particularly those incorporating software
Why Apply?
- Be part of a company in a strong growth phase
- Work on impactful medical technologies
- Collaborate with cross-functional, high-performing teams
- Opportunity to influence quality and continuous improvement initiatives